Feasibility of confocal laser endomicroscopy in bladder cancer digsnosis

Completed

• Conditions: Bladder cancer; urothelial carcinoma; 10038364; 10004994

• Registration Number: NL-OMON45769
• Lead Sponsor: rologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

- Patients >18 years old
- Bladder tumor(s) or possible CIS
- Candidate for TURB
- Signed informed consent

Exclusion Criteria

- Patients <18 years old
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- No signed informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To describe characteristics and define interpretation criteria for CLE imaging,<br /><br>based on direct histopathology correlation of:<br /><br>- Normal or benign bladder tissue<br /><br>- Urothelial carcinoma<br /><br>- Low-grade, high-grade NMIBC or CIS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To develop a CLE image atlas for bladder tumors, benign bladder urothelium and<br /><br>normal urothelium of the lower urinary tract</p><br>